- Merck & Co. (North Wales, PA)
- … development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach.The incumbent will be ... partnership with our research division QA and acting as the link between Clinical Development , study teams, global business functions and regional study… more
- Insmed Incorporated (NJ)
- …Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's possible for patients with ... serious diseases. Reporting to the VP, Clinical Development - Gene Therapy, the Executive...be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring… more
- Bayer (Whippany, NJ)
- …is responsible for leading the strategic conceptualization, design, execution, and oversight of the clinical development programs of diagnostic drug ... Molecular Imaging (MI) assets in Radiology. This role encompasses clinical development phases from Phase 1 to Phase 3, with an emphasis on late-phase … more
- Formation Bio (New York, NY)
- …be part of that journey: As a key member of the team, based on your clinical development experience you will be responsible for providing medical input into our ... Development product assessment strategy and execution, lead the development of the Clinical Development ...strategic input to and monitor the execution of clinical studies as a project physician.Your ability to understand… more
- Insmed Incorporated (NJ)
- …science, we're in. Are you?About the Role:Accountable for providing the leadership, strategic , operational planning and oversight of 1-2 indications within one ... Clinical Operations group including recruitment, training, mentoring, career development , work assignments, performance evaluations and ongoing feedback to and… more
- Merck & Co. (Boston, MA)
- …to our medicines.The Senior Principal Scientist has primary responsibility for protocol development and medical/scientific oversight of clinical research ... of HIV and drug pharmacology to the infectious disease therapeutic area's clinical development strategy and the implementation of short and long-term… more
- Formation Bio (New York, NY)
- …for programs and clinical studies. Collaborate with cross-functional teams ( Clinical Development , Regulatory, Program Management, etc.) to shape and refine ... and AI platforms to enhance efficiency and scalability.ResponsibilitiesProject Management Oversight Provide strategic and tactical guidance for... Clinical Development Plans, ensuring feasibility and operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with development of the clinical database (edit checks, CCG development , and UAT) Study Conduct and Oversight :Ensure operational adherence to the ... timeline, and budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate...with different levels of study governance, as requiredOversee the development of the clinical study plan including… more
- Insmed Incorporated (NJ)
- …gene therapy and large molecule programs, providing strategic direction and oversight throughout the development lifecycle and up through product approvals ... you will lead our gene therapy and large molecules pipeline from preclinical through clinical development and regulatory approvals. In this role you will be a… more
- Merck & Co. (Rahway, NJ)
- …improve, sustain or reposition our Company's relationship with critical/ strategic suppliers. Typical Activities :- Development /participation-in supplier forums, ... will work with regional and local teams to support development and implementation of a sourcing strategy at a...teams through the sourcing process and to provide strategy oversight for regional and/or local components of the category.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … of process-related protocols and documentation.Provide technical quality oversight for electronic batch records.Support manufacturing and technical operations ... Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of… more
- Eisai, Inc (NJ)
- …review charters, site imaging manuals, and transmittal forms-and contribute to the development and approval of clinical data transfer specifications, including ... working on clinical trials with imaging aspects required, from protocol development to final analysis and clinical study reporting.Familiarity with oncology… more
- Formation Bio (New York, NY)
- …In this pivotal role, you will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...development organization, there is a substantial component of oversight for the computer systems validation. The implementation of… more
- Merck & Co. (Rahway, NJ)
- …and identifies value evidence needs to provide strategic input into clinical and market development programs.- Brings strong payer and HTA/reimbursement ... Research Pneumococcal Vaccines team the incumbent has the following responsibilities: Development of the integrated evidence strategy to support Health Technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of ... is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer… more
- Insmed Incorporated (NJ)
- …collaborative partnerships with the cross-functional Insmed team (Medical Affairs, HEOR, Clinical Development , Advocacy, Commercial and Market Access) as well ... in alignment with business strategy, medical affairs strategy, and Insmed clinical development programs.Manage external vendors/medical agencies assisting with… more
- Legend Biotech USA, Inc. (Atlanta, GA)
- …between investigators and members of the Legend Biotech Medical Affairs and Clinical Development teams; Addressing AE management and education as ... level in full alignment with Medical Affairs strategies and tactics.Assist in the oversight of Legend Biotech sponsored clinical trial sites to include, but… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working cross- functionally and in global teams.Strong Industry Network in clinical development . Knowledge and understanding of cultural differences and ... QA Strategy &Operations (Global R&D PV QA) is responsible for providing strategic leadership for QA initiatives across the organization. This role involves… more
- Genmab (NJ)
- …actively as a member of the US Field Medical Affairs Leadership team in strategic planning, execution and reporting oversight of the HEOL TeamPartner effectively ... and Epidemiology) and US Market Access leadership teams for strategic and tactical planning for the US HEOL Team...Team to ensure adequate and appropriate communication of Genmab's clinical and economic value messages. The Director, HEOL Team… more
- Merck & Co. (North Wales, PA)
- …deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.Be accountable for submission data standards ... and information into simple readable form.Solid project management skills.Familiarity with clinical data management concepts. Strategic thinking ability to turn… more
